HCV CHRONIC INFECTION TREATMENT WITH DAA: WHO ARE THE PATIENTS THAT ARE NOT ACHIEVING SUSTAINED VIROLOGIC RESPONSE?

Transcription

1 HCV CHRONIC INFECTION TREATMENT WITH DAA: WHO ARE THE PATIENTS THAT ARE NOT ACHIEVING SUSTAINED VIROLOGIC RESPONSE? R U I V A L E N T E 1, R I T A G R Á C I O 2, M I G U E L A C H E G A 3, A N A C L Á U D I A M I R A N D A 4, T E R E S A B A P T I S T A 4, J A I M E N I N A 4, F E R N A N D O V E N T U R A 4, S U S A N A P E R E S 4, I S A B E L A L D I R 4, F E R N A N D O B O R G E S 4, I S A B E L A N T U N E S 4, M A R I A J O S É C A M P O S 5, J O Ã O P E R E I R A 6, K A M A L M A N S I N H O 4 1 Serviço de Medicina Interna - Hospital Beatriz Ângelo 2 Serviço de Medicina I - Centro Hospitalar de Leiria 3 Serviço de Medicina II - Hospital Prof. Dr. Fernando da Fonseca 4 Serviço de Infecciologia e Medicina Tropical - Hospital de Egas Moniz Centro Hospitalar de Lisboa Ocidental 5 Serviço de Urgência Centro Hospitalar de Lisboa Ocidental 6 Serviço de Medicina 1 Hospital de Egas Moniz - Centro Hospitalar de Lisboa Ocidental

2 BACKGROUND Hepatitis C virus (HCV) is a major healthcare problem. Recent advances in the HCV treatment after the introduction of direct acting antiviral (DAA) brought a change in the quality of life and life expectancy of these patients. The aim of this study is to characterize the patients treated with DAA for chronic hepatitis C who did not achieve sustained virological response (SVR), with special focus on those HIV co-infected.

3 MATERIALS & METHODS Retrospective, observational study. Individual clinical file review of HCV chronically infected patients, with regular follow-up on an outpatient Infectious Diseases clinic who were eligible to start DAA treatment. From1 st January 2015 to 30 April Demographic and HCV infection features, liver disease staging, therapeutic regimen and response to therapy. Data was analyzed using Microsoft Office Excel 2010.

4 1 st January April patients proposed to hepatitis C DAA treatment DEMOGRAPHICS Mean age [min;max] 49,8 years [33;78] Men / Women (%) 76% / 24% Mean time HCV diagnosis 14,2 years [1;30] HIV co-infection (n, %) 338 (63,5) HCV treatment experienced (n, %) Tabela 157 (29) TRANSMISSION n (%) IV drug use 353 (66%) Sexual 37 (7%) Transfusional 6 (1%) Unkown 37 (7%) NA 99 (18%) HCV GENOTYPE n (%) G1 323 (60%) G2 9 (1,2%) G3 99 (18%) G4 100 (18%) G6 1 (0,1%) FIBROSIS (METAVIR) n (%) F2 222 (42%) F3 246 (46%) F4 54 (10%) MELD SCORE >= (12%) NA: Not available

5 1 st January April patients proposed to hepatitis C DAA treatment 464 (87%) started DAA 68 (13%) did not start DAA 3 died 31 OT Sepsis n=1 ESLD n=1* HCC n=1* 430 (81%) completed tx 359 (67,5%) performed 12/24 week post tx evaluation 58 (85%) waiting tx 5 (7%) died Sepsis n=2* Lung Cancer n=1* Lymphoma n=1* Chronic liver disease n=1* 5 (7%) lost to follow up Global SVR 96,1% (345/359) * HIV coinfected

6 1 st January April patients proposed for hepatitis C DAA treatment SOF/LED 74% SOF+RBV SOF/LED+RBV 18% Other SOF+DAC OMB/PTVr/DBV OMB/PTVr/DBV+RBV HIV/HCV HCV Global

7 1 st January April patients proposed for hepatitis C DAA treatment 430 (81%) completed tx 359 (67,5%) performed 12/24 w post tx evaluation SVR VHC VHC/VIH Global SVR 96,1% 98% 97% 100% 97% 100% 100% 100% 98% 96% 84% 100% 118/122 31/30 55/56 25/25 4/4 4/4 26/26 38/39 13/16 48/50 1/1 0% G1a G1b G2 G3 G4 G6

8 14 (3,9%) patients did not achieve sustained virologic response (SVR) DEMOGRAPHICS GENOTYPE n (%) Mean age [min;max] 54 [43;78] Men / Women 93% / 7% HIV co-infection 9 (64 %) HCV treatment experienced 11 (78%) TRANSMISSION n (%) IV drug use 8 (57,14) NA 2 (14,2) G1 5 (35) G2 1 (7) G3 4 (28) G4 4 (28) FIBROSIS (METAVIR) n (%) F2 7 (50) F3 7 (50) MELD SCORE > 10 0 Transfusional 1 (7,14) Unkown 3 (21,4)

9 14 (3,9%) patients did not achieve sustained virologic response (SVR) GENOTYPE FIBROSIS SCORE % G1a G1b G2 G3 G4 F2 F2/F3 F3 F4

10 14 (3,9%) patients did not achieve sustained virologic response (SVR) DAA ORIGINAL REGIMEN SOFOSBUVIR+LEDIPASVIR 9 Patients (G1/G4) 5 Cirrhotic - 24 Wks 4 non Cirrhotic - 12 Wks SOFOSBUVIR+RIBAVIRIN 4 Patients (G2/G3) 4 Cirrhotic - 24 Wks SOFOSBUVIR+DACLATASVIR 1 Patient (G3) Non-Cirrhotic - 12 Wks

11 14 (3,9%) patients did not achieve sustained virologic response (SVR) RETREATMENT REGIMENS WERE SOLICITED FOR 8 PATIENTS AT PRESENT DATE ORIGINAL REGIMEN PROPOSED RETREATMENT SOF+LE D SOF+GZV/EBR+RBV 24 wks 5 SOF+RB V SOF+DAC+RBV 12 wks 3

12 CONCLUSIONS The treatment of hepatitis C virus infection was revolutionized by the introduction of the direct antiviral agents, which achieve high rates of virologic response. Although the treatment is very effective there are still patients who do not respond to therapy. The present study reveals a low relapse rate (3,9%) and the majority of non-responders were men, previously treated with PEGIFN+RIB, HCV infected by intravenous drug use, co-infected with HIV and have moderate/advanced hepatic fibrosis (F2-F3).

13 Acknowledgements Fernando Borges Fernando Ventura Pedro Brogueira Joana Silva Director: Kamal Mansinho Jaime Nina João Vaz Alves Isabel Antunes Karen Pereira Isabel Aldir Sara Grazina Molecular Biology: Perpétua Gomes Teresa Baptista João Torres Pharmaceutical: João Rijo, Helena Farinha Ana Cláudia Miranda Margarida Cardoso Secretary: Hermínia Calixto Susana Peres Miguel Achega Virginia Moneti Rita Grácio Telma Azevedo